MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2014-02-11 for COBAS 6000 E601 MODULE 04745922001 manufactured by Roche Diagnostics.
[4134710]
The customer received a questionable antibody to hepatitis c virus (anti-hcv) result for one patient. The result from the cobas e 601 analyzer was 0. 459 coi (non-reactive). On (b)(6) 2014, the result from the abbott architect i1000 analyzer was 2. 93 s/co(positive). The result of 0. 459 coi was reported outside the laboratory. The patient was not adversely affected. The anti-hcv reagent lot number was 175153 with an expiration date of 06/29/2014.
Patient Sequence No: 1, Text Type: D, B5
[11624465]
The investigation could not determine a specific root cause. Additional information for further investigation was requested, but was not provided. It was also noted that no patient sample could be provided for further investigation.
Patient Sequence No: 1, Text Type: N, H10
[11643668]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2014-00902 |
| MDR Report Key | 3622930 |
| Report Source | 01,05,06 |
| Date Received | 2014-02-11 |
| Date of Report | 2014-02-26 |
| Date of Event | 2014-01-25 |
| Date Mfgr Received | 2014-01-28 |
| Date Added to Maude | 2014-02-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | NA MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| Manufacturer G1 | HITACHI HIGH TECH CORP. |
| Manufacturer Street | 882 ICHIGE HITACHINAKA NA |
| Manufacturer City | IBARAKI 312-8504 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 312-8504 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS 6000 E601 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | MZP |
| Date Received | 2014-02-11 |
| Model Number | NA |
| Catalog Number | 04745922001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-02-11 |